Development Medical

CURRICULUM VITAE

Gene C. Kopen, Ph.D.

Contact information:

Home: 610-***-****

Cell: 484-***-****

Email: abhrz6@r.postjobfree.com

RELATED PROFESSIONAL EXPERIENCE

Life Science Executive with over 15 years experience developing products and manufacturing

technology processes in the field of Regenerative Medicine. Experienced in creating/growing value

for venture backed, Biotech companies through scientific and operational oversight of various

functional areas/departments.

SUMMARY OF QUALIFICATIONS

Executive Management

Highly experienced at setting corporate goals/objectives/operating plans, and achieving

•

milestones on time and within budget.

Highly experienced at solving complex problems by integrating information across multiple

•

disciplines/perspectives, and then implementing attainable action plans to meet corporate

goals/objectives.

Highly competent at multitasking and get things done within a changing business

•

environment.

Highly experienced at growing/managing relationships.

•

Highly experienced at setting/managing expectations of stakeholders, shareholders.

•

11 years experience working with Venture Capital professions/investors.

•

Experienced in managing/preparing for, 3rd party due diligence.

•

Experienced in managing CRO/CMO/Patent Counsel, other external relationships.

•

Experience in identifying/growing other business opportunities and/or to creating additional

•

upside for company.

See concepts of “ownership, inclusiveness, respect, and candor” as key factors to success of an

•

organization.

Belief that focus and execution when aligned with flexibility, creativity, and common sense

•

gets company to the goal line.

Manufacturing & Process Development

Highly experienced in area of Manufacture of off the shelf, allogeneic cell therapy products

•

and their derivatives (e.g. bioactive medical devices, other extractable therapeutics) My prior

position was responsible for oversight of Manufacturing & Process Development, utilizing a

2000 square feet GMP practice compliant space which included a 500 square foot clean room,

as well as third party manufacture (secondary site), testing, and storage of the company’s

clinical products.

Inventor/co inventor around methods of commercial manufacture/scale up of cell

•

compositions and bioactive medical devices (65+ patent applications/patents worldwide).

Basic and Applied Research

PhD in Molecular Pathophysiology.

•

Extensive Research experience in several therapeutic areas: Stem Cell Biology, Wound Repair,

•

Spinal Cord injury, Cadiovascular (Stroke, AMI), and Inflammation.

Strong scientific background in Cell Biology, Immunology, and Pathobiology.

•

Well versed in design and execution of many types of in vitro and in vivo cell & molecular

•

assays/model systems, in addition to those required to support regulatory filings.

Designed & implemented various GMP testing parameters/specs over the years, many now in

•

use in release/stability testing of Product.

Preparation of numerous presentations for scientific, investor, BOD, and clinical advisory

•

forums.

Clinical

Highly experienced managing relationships with KOLs.

•

Experienced with clinical trial protocol design, implementation, practice and GCP compliance

•

(particularly Phase I, II).

• Experienced managing/coordinating various team to meet clinical goals, deadlines

Regulatory

Experienced interfacing with FDA.

•

Experience in writing/responding to FDA communications, particularly around CMC & pre

•

clinical Pharm/tox.

Experience with cGXPs, IHC, other regulatory guidance documents/process around

•

development of Biologics.

Management/Protection of Intellectual Property

Experienced in patent prosecution procedure, developing patent strategy/claim

•

language/rebuttals/declarations, etc., FTO analyses, etc.

Familiar with Appeal process, Annuity process, foreign filings, and other related matters.

•

EMPLOYMENT HISTORY

11/2008 10/2010 Chief Scientific Officer & Sr. Vice President, Technology

Development & IP Management, Garnet BioTherapeutics, Inc.

Responsibilities Included:

• Developing strategic goals/objectives for R&D, Manufacturing, and IP supporting/driving

operating plans, budgets, timelines and deliverables.

• Managing departments of Research Operations & Manufacturing/Process Development (VP of

Research Ops. and Dir of Manufacturing reported to me, and I reported to CEO).

• Developing new methods for scale up manufacture through coordinated efforts of

Manufacturing/Process Development team, 3rd party engineers and consultants.

• Building out a tissue engineering program initiative to develop Biomedical Device prototypes for

IDE filing in 2011.

• Identifying new clinical program/partnering opportunities by working with executive

management, Board of Directors, consultants, and outside thought leaders.

• Protecting company inventions/trade secrets, developing patent strategy, surveying patent

landscape of competing art, supervising 3rd party patent counsel activities related to all patent

matters.

• Corporate Secretary.

Accomplishments:

Completed IND enabling pre clinical pharmacology and toxicology studies, filed IND,

•

commenced clinical trial NCT01053897 for treatment of incisional wounds.

Developed novel method for administering cell therapy this method is currently being used

•

clinically.

Conceived of, and built (via 3rd party contractors) novel method for scale up manufacture of

•

mammalian cells current method used in GMP manufacture of medical devices.

Transferred GMP manufacturing and testing methods to 3rd party contractor, through which 4

•

GMP lots of cell product have since been produced. Timeframe (tech transfer, method validation,

& completion of engineering runs): 6 months.

Developed GMP grade medical device for use in treatment of soft tissue injuries. Time frame

•

(from Research prototype to 1st GMP batch): 7 months.

Filed multiple provisional patent applications, as well as several other patent applications, entered

•

national stage in 40+ countries, completed several freedom to operate analyses, numerous other

rebuttals, declarations.

Developed an equine cell therapy product/program, established testing for release/stability.

•

Timeframe (procurement of 1st donor, expansion & characterization of cell banks, tech transfer of

testing methods to analytical lab): 6 months.

Conducted 3 cadaveric studies to test feasibility of medical device (2 human hand studies) and

•

ultrasound guided injection of equine cells (1 equine flexor tendon study). Timeframe: 4 months.

Build out of GMP suite/clean room, in which 1 lot of medical devices, & several lots of equine

•

cell banks were manufactured. Timeframe: less than one year.

11/2007 10/2008 Vice President, Technology Development & IP Management,

Neuronyx, Inc.

Responsibilities Included:

Developing, implementing, and executing operating/strategic plans pertaining to Manufacturing,

•

Process Development, Research, and IP matters.

Developing and implementing new technology initiatives.

•

Oversight of all patent matters.

•

Initiating/supporting business development efforts.

•

Establishing and managing a network of technical experts, industry thought leaders, and academic

•

collaborators to support new clinical direction of product development.

Accomplishments:

Developed plans to reduce operating costs, increase flexibility/productivity through outsourcing

•

various efforts. Hired Quality Assurance consultant to ensure Regulatory/Quality compliance.

Coordinated team efforts to assess 3rd party CMO for outsource manufacture & testing/storage of

•

lead product, GBT009, as well as critical cell banks.

Coordinated/facilitated in house team efforts for around extensive 3rd party due diligence.

•

Coordinated/facilitated transition of various facets of business during reorganization.

•

6/2007 10/2007 Sr. Director, Technology Development, Neuronyx, Inc.

Responsibilities Included:

• Developing new clinical program opportunities leveraging platform technology.

• Developing strategic R&D objectives supporting/driving operating plans.

• Managing milestone driven projects leading to value adding product development and process

development opportunities.

• Managing Intellectual property portfolio.

• Developing new technologies for next generation of biopharmaceuticals.

• Directing core projects aimed at Cell Product characterization.

• Managing IND enabling pre clinical research conducted through key academic collaborations and

contract research organizations.

Accomplishments:

Filed four patent applications.

•

Identified ways to enhance product manufacture at lower cost of goods.

•

Identified methods for developing new product prototypes.

•

Built relationships with collaborators/area experts to support clinical rationale for use of lead

•

product, GBT009 in dermal indication.

2003 5/2007 Sr. Scientist, Neuronyx, Inc.

Responsibilities Included:

• Developing strategic R&D objectives supporting/driving operating plans.

• Managing milestone driven projects leading to value adding product development and process

development opportunities.

• Developing new clinical program opportunities leveraging platform technology.

• Directing core projects aimed at Product characterization, MOA

• Managing IND enabling pre clinical research conducted through key academic collaborations and

contract research organizations.

• Managing Intellectual property portfolio (took on this responsibility in 2005).

Accomplishments:

Area expert of Cardiovascular team IND compiled, submitted and cleared for Phase I clinical

•

Trial in Sub Acute Myocardial Infarction (NCT00361855).

Lead project team responsible for development and implementation of various GMP

•

processes/specifications for Manufacture/testing of cell therapy Product.

Directed design and execution of various pharmacology and toxicology studies supporting Stroke

•

clinical development, some of which where conducted through sponsored research leading to

Grant from Department of Health and Human Services, State of Illinois.

Managed 3rd party collaborations to complete pre clinical pharm studies.

•

Directed Research team/projects resulting in new technologies/IP

•

2000 2003 Scientist, Neuronyx, Inc.

Responsibilities included:

Developing technologies for isolation and ex vivo expansion of various human stem cells and

•

somatic cells.

• Implementing/managing an in house spinal cord injury (SCI) program to study therapeutic

potential of cell prototypes.

• Designing & executing in vitro & in vivo projects aimed at cell differentiation, characterization,

and manufacture, as well as, pre clinical development of cell prototypes.

• Recruiting and training key positions for R&D and early phase Manufacturing.

• Managing IND enabling pre clinical research/relationships through key academic collaborations

and contract labs.

Accomplishments:

Developed/patented ex vivo expansion technologies for human stem cells; this early work quickly

•

lead to the development of a scale up platform for GMP manufacture of company’s cell based

product, yielding approximately 5 x 109 clinical doses of human cells from a single donor.

Assembled a pre clinical SCI team in tandem with an academic collaboration that lead to the

•

completion of 11+ pre clinical studies supporting path to IND in less than two years.

Designed/executed many pre clinical studies, wrote SOPs for surgical & LAF procedures, trained

•

personnel on Keck Center model of spinal cord contusion with BBB, managed staff of about 8 10

scientists/research associates.

Authored several manuscripts on this work.

•

1999 2000 Post Doctoral Fellow, Center for Gene Therapy, MCP Hahnemann University,

Philadelphia, PA.

Selected Scientific Projects (much of this work was initiated in parallel with my dissertation

research):

Development of new methods for isolation and ex vivo expansion of bone marrow stromal

•

cells (MSC).

Characterization of murine and human derived MSC by flow cytometry, in vitro

•

differentiation, in vivo pharmacology, as well as various molecular techniques.

Identification of therapeutic potential of MSC in animal model of storage disease (MPS VII).

•

Development of in vitro differentiation assays aimed at mesenchymal to epithelial

•

differentiation of MSC.

1995 1999 Graduate Student. Doctoral Program Molecular Pathobiology, MCP

Hahnemann University, Philadelphia, PA.

Mentor: Darwin Prockop M.D, Ph.D. Center for Gene Therapy

Thesis: Murine Bone Marrow Stromal Cells: Characterization, Isolation, and

Differentiation

Other: Vice President, Student Government, Graduate Admissions committee

member

1993 1995 Clinical Laboratory Manager, Department of Pathology, Medical College of

Pennsylvania, Philadelphia, PA

Responsibilities included:

Supervision of all facets of diagnostic Immunohistochemistry (IHC) and assay development for 10

•

+ area hospitals and research institutions.

Conducted Image analyses of breast cancers for ER/PR.

•

DNA ploidy by Flow Cytometry.

•

Conducted diagnostic Immunofluorescence on renal and skin bx.

•

Stat cryosectioning and histology on surgically resected bx .

•

Training cytology students and local researchers on methods of IHC.

•

Developed and optimized techniques for diagnostic detection of various tissue antigens.

•

Patient billing and lab QC.

•

Other duties included examination, processing, and dictation of gross exam on surgical specimens.

•

Autopsy duties, when needed, included organ removal and processing for histopathology.

1992 1995 Research Associate, (part time) Department of Pathology, Medical College of

Pennsylvania, Philadelphia, PA. Laboratory of James England, MD., Ph.D.

Lab focus was study of oncogenic events responsible for mesothelioma formation and

V SRC mediated tumor formation, metastasis, and immunologic clearance.

1995 Student Volunteer, Labor and Delivery, Ob/Gyn, Hospital of the

University of Pennsylvania, Phila., PA. (Part time, Summer)

Volunteer training program. Program objective to give pre doc students clinical exposure.

1990 1992 Research Associate, Department of Pathology, Medical College of

Pennsylvania, Philadelphia, PA. (Full time) Laboratory of James England, MD., Ph.D.

Lab focus was study of immunologic mechanisms controlling V SRC induced tumor cell growth and

metastasis. This work was conducting in collaboration with Michael Halpern, Ph.D, of the Wistar

Institute, Philadelphia, PA.

1990 Psychiatric Technician, Eastern Pennsylvania Psychiatric Institute

(Full time, Summer)

Principle responsibilities included, conducting patient history & physical assessment for new

admissions. Patient support & monitoring, maintaining patient compliance to therapeutic regiments.

1988 Sales & Marketing, Eastern Telephone Systems, Fort

Washington, PA. (Full Time)

Sales and marketing of commercial services, client services.

1987 Internship, Kidder, Peabody, & Co, Tampa, Fl. Brokerage and Client Services.

EDUCATION AND TRAINING

B.A. Social & Behavioral Sciences, 1987

Univ. of South Florida, Tampa, FL

Ph.D. Molecular Pathobiology, 1999

Drexel College of Medicine, Phila., PA

PATENTS/PATENT APPLICATIONS

Inventor on 65+ patent/patent applications worldwide covering compositions, methods of making and

use of Cell Therapies and their derivatives, as well as, Bioactive Medical Devices (furnished upon

request)

SELECTED ABSTRACTS AND PUBLICATIONS

ABSTRACTS

Heimbach B, Mack R, Ragaglia V, and G Kopen (2010) Allogeneic adult bone marrow derived

somatic cells enhance wound healing and reduce scarring in Yucatan miniature swine. Wound Repair

& Regen 18(2): BRG05 88.

Heimbach B, Kopen G, Ragaglia V and W Righter (2010) Characteristics of a non hematopoietic

allogeneic bone marrow derived cell population that can be manufactured to pharmaceutical standards

and quantities. 16th Annual ISCT Meeting, Poster #90

Heimbach B, Kopen G, Ragaglia V and W Righter (2010) Functional characteristics of human adult

bone marrow derived somatic cells: A unique population of mesenchymal support cells. 16th Annual

ISCT Meeting, Poster #76

PUBLICATIONS

England, J.M., Panella, M.J., Kopen, G.C., Wisner, T.W., and Halpern, M.S. (1994) Tumor cells

induced by the v src oncogene are heterogeneous for expression of markers of mesenchyme

differentiation. Virchows Archiv. 424 (1): 83 8.

Taylor, R.L., England, J.M., Kopen, G.C., Christou, A.A., and Halpern, M.S. (1994) Major

histocompatibility (B) complex control of the formation of v src induced metastases. Virology. 205

(2): 569 73.

Appelt, D.M., Kopen, G.C., Boyne, L.J., and Balin, B.J. (1996) Localization of transglutaminase in

hippocampal neurons: implications for Alzheimer’s disease. J. of Histo.& Cytochem. Dec; 44 (12):

1421 7.

Taylor, R.L., England, J.M., Kopen,G.C., Christou, A.A., and Halpern, M.S.

(1996) Sequence variation in the src gene product affects metastasis formation: the central, but not

exclusive, role of the tumor immune response. International J. of Cancer. Oct. 9; 68 (2): 228 31.

Halpern, M.S., England, J.M., Kopen, G.C., Christou, A.A., and Taylor, R.L. (1996). Endogenous c

src as a determinant of the tumorigenicity of src oncogenes. Proceedings of the National Academy of

Sciences of the United

States. 93 (2): 824 7.

Li,S.W., Arita, M., Kopen.G.C., Phinney, D.G., and Prockop, D.J. (1998) A 1,064 bp fragment from

the promoter region of the col11a2 gene drives LacZ expression not only in cartilage but also in

osteoblasts adjacent to regions undergoing both endochondrial and intermembranous ossification in

mouse embyos. Matrix Biology. July; 17(3): 213 221.

Phinney, D.G., Kopen, G.C., Isaacson, R.L., and Prockop, D.J. (1999) Plastic Adherent stromal cells

from the bone marrow of commonly used inbred strains: variations in yield, growth, and

differentiation. Journal of Cellular Biochemistry. 15:72(4): 570 585.

Phinney, D.G., Kopen,G.C, Righter,W., Webster, S., Tremain, N., and Prockop, D.J. (1999) Donor

variation in the growth properties and differentiation potential of the human marrow stromal cells.

Journal of Cellular Biochemistry. 75: 424 436.

Kopen, G.C., Prockop, D.J., and Phinney, D.G. (1999) Enhanced in situ detection of β glucuronidase

activity in murine tissue. Journal of Histochemistry and Cytochemistry. 47(7): 965 968.

Kopen, G.C., Prockop, D.J., and Phinney, D.G. (1999) Marrow stromal cells migrate throughout

forebrain and cerebellum and they differentiate into astocytes following injection into neonatal mouse

brain. Proc Nat’l Acad Sci USA. 96:107**-*****.

Prockop, D.J., Azizi, S.A., Colter, D., DiGirolamo, C., Kopen, G.C., and Phinney, D.G. 2000.

Potential use of stem cells for bone marrow to repair the extracellular matrix and the central nervous

system. Biochem. Society Transactions. 28(4): 341 5.

Prockop DJ, Azizi SA, Phinney DG, Kopen GC, Schwarz, EJ. 2000. Potential use of marrow stromal

cells as therapeutic vectors for diseases of the central nervous system. Prog. Brain Res. 128: 293 7.

Li, S., Arita, M., Fertala, A., Bao, Y., Kopen, G.C., Langsjo, T., Helminen, H.J., and Prockop, D.J.

2001. Transgenic mice with inactive alleles for procollagen N proteinase (ADAMTS 2) develop

fragile skin and male sterility. Biochem. J. Apr 15:355 (pt2): 271 8.

Arita M, Li SW, Kopen G, Adachi E, Jimenez SA, Fertala A. 2002. Skeletal abnormalities and

ultrastructural changes of cartilage in transgenic mice expressing a collagen II gene (COL2A1) with a

Cys for Arg alpha1 519 substitution. Osteoarthritis Cartilage. Oct: 10(10): 808 15.

Tremain N, Korkko J, Ibberson D, Kopen GC, DiGirolamo C, Phinney DG. 2001. MicroSAGE

analysis of 2,353 expressed genes in a single cell derived colony of undifferentiated human

mesenchymal stem cells reveals mRNAs of multiple cell lineages. Stem Cells. 19(5): 408 18.

Baddoo M, Hill K, Wilkinson R, Gaupp D, Hughes C, Kopen GC, Phinney DG. 2003.

Characterization of mesenchymal stem cells isolated from murine bone marrow by negative selection.

J Cell Biochem. Aug 15; 89(6):1235 49.

Himes BT, Neuhuber B, Coleman C, Kushner R, Swanger SA, Kopen GC, Wagner J, Shumsky JS,

Fischer I. 2006 Recovery of function following grafting of human bone marrow derived stromal cells

into the injured spinal cord. Neurorehabil. Neural Repair. Jun; 20(2): 278 96.

Andrews EM, Tsai SY, Johnson, SC, Farrer JR, Wagner JP, Kopen GC, Kartje, GL. 2008. Human

adult bone marrow derived somatic cell therapy results in functional recovery and axonal plasticity

following stroke in the rat. Experimental Neurology. 211: 588–592.

Contact this candidate